Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. |
| Product | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 |
| Quantity | 47 units |
| Distribution | Nationwide including Puerto Rico Foreign: To be provided |
| Initiated | 2024-12-20 |
| Classified | 2025-01-30 |
| Recall number | Z-1029-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1029-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96049/
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